Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089323
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2004-08-04
Brief Title:
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I Stage II or Stage IIIA Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
Bone Marrow Analysis In Early-Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment
PURPOSE This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I stage II or stage IIIA breast cancer
PURPOSE This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I II or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry
Secondary
Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients
OUTLINE This is a multicenter study
Patients undergo bone marrow aspiration during surgical resection of the primary tumor Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry
Patients are followed every 12 months for up to 10 years
PROJECTED ACCRUAL A total of 1634 patients will be accrued for this study within 3 years
Primary
Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I II or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry
Secondary
Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients
OUTLINE This is a multicenter study
Patients undergo bone marrow aspiration during surgical resection of the primary tumor Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry
Patients are followed every 12 months for up to 10 years
PROJECTED ACCRUAL A total of 1634 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSABP-BP-59 | None | None | None |